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IDARUBICIN HYDROCHLORIDE

ANDA

IDARUBICIN HYDROCHLORIDE | A065036 | MEITHEAL PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: IDAMYCIN PFS(TE code: AP)

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVIDARUBICIN HYDROCHLORIDE

DMF 138841998

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveIDARUBICIN HYDROCHLORIDE

DMF 160572002

SYNBIAS PHARMA AGInactiveIDARUBICIN HYDROCHLORIDE

DMF 175042004

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveIDARUBICIN HYDROCHLORIDE USP

DMF 196132006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 5MG/5ML (1MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 1, 2002

No patent or exclusivity listings for this strength.

#002 — 10MG/10ML (1MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 1, 2002

#003 — 20MG/20ML (1MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 1, 2002